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AzTrials

Endometrial CancerEarly Phase 1NCT05320757

Effects of PARP Inhibitor on Tumor Microenvironment in High-risk Endometrial Cancer Patients

A Early Phase 1 study testing Olaparib in people with Endometrial Cancer, run by The University of Hong Kong at 1 site in Hong Kong.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is a window study where treatment-naïve patients will receive olaparib before definitive treatment. The aim is to evaluate the DNA damage and inflammatory response after PARP inhibitor. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Endometrial Cancer
What is being tested?
Olaparib
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteHong Kong
Study dates
1 Apr 2022to 31 May 2025
Phase
Early Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients must be capable of giving signed informed consent
  • Patients must be at least 18 years old
  • Patients must have newly diagnosed and histologically confirmed high-risk endometrial cancer, including:
  • G3 endometrioid, any stage
  • Type 2 (such as serous, clear cell, carcinosarcoma), any stage
  • G1 endometrioid, stage 2 or beyond
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  • The endometrial cancer should be visible on pre-treatment ultrasound, or endometrial lining should be 5mm or above
  • An archived FFFE sample of endometrial biopsy or at least 8 unstained slides should be available
  • Patients should have Eastern Cooperative Oncology Group (ECOG) performance score 0 to 1
  • Patients must have adequate bone marrow, renal, hepatic, thyroid and neurological function within 28 days prior to administration of study treatment
  • Patients must be able to swallow oral medication
  • Patients must have a life expectancy of ≥ 16 weeks
  • Patients must either be postmenopausal or show evidence of non-childbearing status for women of childbearing potential

Who cannot join

  • Patients with other malignancy unless curatively treated with no evidence of disease for >= 5 years, are excluded.
  • Patients whose resting ECG indicating uncontrolled, potentially reversible cardiac conditions, or patients with congenital long QT syndrome, are excluded.
  • Patients with myelodysplastic syndrome/acute myeloid leukaemia or with features suggestive of MDS/AML, other hematological diseases such as venous or arterial thrombosis and thrombocytopenia are excluded.
  • Patients with symptomatic uncontrolled brain metastases are excluded.
  • Patients who are unable to swallow orally administered medication and gastrointestinal disorders are excluded.
  • Patients with immunocompromised condition, active hepatitis, or persistent toxicities caused by previous cancer therapy, are excluded.
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  • 9. Concomitant use of known strong CYP3A inhibitors or inducer are excluded. 10. Patients who have major surgery within 2 weeks, previous allogenic bone marrow transplant, are excluded.
  • 11. Patients with a known hypersensitivity to olaparib or any of the excipients of the product are excluded.
  • 12. Use of an investigational drug within 30 days or 5 half-lives, whichever is longer, proceeding the first dose of study drug is not allowed.
  • 13. Pregnant or breastfeeding women are excluded. 14. Patients who are judged by the investigator to be unlikely to comply with study procedures, restrictions and requirements are excluded.

Trial locations and contacts

1 site in 1 country.

Hong Kong1 site

  • The University of Hong Kong

    Hong Kong

Other trials in Hong Kong

About this study

This is a window study where treatment-naïve patients will receive olaparib before definitive treatment. The aim is to evaluate the DNA damage and inflammatory response after PARP inhibitor.

Read the detailed description

Patients with high-risk endometrial cancers are prone to develop recurrence. The response rate to conventional chemotherapy in persistent or recurrent endometrial cancer is poor. Recent research demonstrated that immune checkpoint with or without targeted therapy was an effective treatment option. However, the change of immune landscape in the blood and tumor after PARPi is not clear.

Being tested
Olaparib
Keywords
Endometrial cancer, olaparib
Medical subject headings
Endometrial Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • OlaparibDrug

    Also called Lynparza

    a PARP inhibitor

Study groups in NCT05320757
Study groupRoleWhat they receive
OlaparibExperimentalOlaparib: 300mg BID orally for 10 - 28 days (stop 3 - 4 days before definitive treatment)
Receives: Drug: Olaparib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Extent of DNA damage

    change of gH2Ax expression in tumor tissues in high-risk EC patients before and after olaparib as assessed by immunofluorescent staining (% change)

    Measured: Up to 18 months

Secondary outcomes (2)

  1. Change of CD4 and CD8 T cells in tumor

    Change of T cell population in tumours before and after olaparib as assessed by immunostaining (% change)

    Measured: Up to 18 months

  2. Change of interferon gamma level in blood

    Change of interferon gamma in blood before and after olaparib as assessed by ELISA (% change)

    Measured: Up to 18 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Apr 2022
  2. Study start1 Apr 2022
  3. Primary completion31 May 2025
  4. Study completion31 May 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Early Phase 1
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05320757
Sponsor's protocol ID
UW 21-521
Status last verified
Jun 2025
First submitted
23 Feb 2022
Last updated
11 Jun 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing Olaparib in people with Endometrial Cancer, run by The University of Hong Kong at 1 site in Hong Kong.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Extent of DNA damage (time frame: Up to 18 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05320757.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2025.

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